Emulsion blocking latex protein and other skin irritants

ABSTRACT

The present invention relates in general to a medical device consisting of a blocker made of a mixture of natural products such as African palm oil and the triglycerides thereof and natural waxes as active and emulsifying components, polymer and silver nanoparticles, acting as a blocker for latex protein and other skin irritants.

This application is a divisional application of U.S. application Ser.No. 15/314,239, with a filing date of Nov. 28, 2016, which is the U.S.National Phase of International Application No. PCT/CR2014/000002, filedMay 26, 2014, the disclosure of which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates in general to a medical device consistingof a blocker made of a mixture of natural products, such as African palmoil and the triglycerides thereof, and natural waxes as active andemulsifying components, polymer and silver nanoparticles, acting as ablocker for latex protein and other skin irritants.

BACKGROUND OF THE INVENTION

Latex allergy represents a real problem of public health worldwide, and,despite multiple efforts to solve this situation, no other substitutematerial having the same characteristics that made latex a successfulproduct has been discovered to date. However, thanks to biotechnologybased on surface chemistry and microfilm technology, the presentinvention succeeds in providing a solution to this condition.

The latex products industry uses about 4.5 million tons of latex peryear (5). This material is used in the manufacture of rubber pumps,condoms, electrical materials, gloves and other products for medicaluse. This polymer is related to many daily-activities of healthpersonnel, especially when using gloves or disposable medical materials(1, 2)

Latex is the second most common cause of anaphylactic reaction inoperating rooms (16.6% of cases). However, the incidence has declined inresponse to the identification of patients at risk, improvements inlaboratory determinations, and introduction of measures for theprevention and reduction of latex in many medical products.

The prevalence of sensitization to latex is less than 1% in the normalpopulation without atopy, but in health personnel it fluctuates between3 and 12%. (6, 9, 11)

Using the determination of IgE in serum (specific against latex), 4-6.4%of individuals are positive (14). The incidence of latex sensitization(measured as a level of specific IgE) in ambulatory surgical patients is6.7% (9). The prevalence of latex allergy in the general population is0.7-11%. (15)

In a group of non-sensitized individuals who began to work in health, itwas demonstrated that there was a 6.4% cumulative incidence of skinsensitivity, 1.8% for people with rhinoconjunctivitis, and 4, 5% forthose with occupational asthma. (21)

High-risk latex allergy groups include: health workers, workers withoccupational exposure to latex (police officers, stylists, foodhandlers), individuals with a history of atopy, and patients with spinabifida and genitourinary abnormalities requiring multiple surgicalinterventions. (9, 11, 16, 17)

Patients with spina bifida, even without multiple surgeries, are atincreased risk. The most frequent manifestation in spina bifida isurticaria (8, 9, 18, 22). Obojski. (23) reported respectively 32.4% and18.8% prevalences in boys and girls when sensitized and suffering fromallergy to latex. In children with spina bifida and congenital diseasesrequiring multiple surgeries, the frequency is reported to be between23-70% (10, 17, 18, 22).

Health workers are the main risk group due to constant exposure to latexproducts; the frequency of sensitization in the hospital populationfluctuates between 2.8-17%. In other occupations with latex exposure,the frequency ranges from 5-11%. Allergy in health workers with latexallergy is 2.2-4.2 times more frequent than in control workers. Inadults with latex allergy, a prevalence of up to 82% is reported (17). Ahealth worker who is atopic has an increased risk of sensitization andallergy to latex.

Anesthesiologists have a 12.5% and 2.4% prevalence of sensitization andallergy to latex respectively (23). Anesthesiologists treating adultschange their gloves more often than those treating children and have ahigher sensitivity to latex, those affected being estimated to be 24%.(9, 24)

Although the latex industry has tried to solve the problem of allergies,this has not been achieved by any technique, including: talc treatment,multiple washes, chlorination, hydrogel treatments, PVC gloves, neoprenegloves, Styrene block copolymer gloves, and even polyurethane gloves.But none of these managed to even lessen the problem.

The other materials that are currently available have not been able toreproduce the main benefits of latex, which are price, sensitivity,durability, and memory that keeps the gloves shape when they stretch,even with the most demanding maneuvers.

Latex protein: Natural latex is a milky liquid from the HeveaBrasiiensis tree. Its matrix contains soluble and insoluble proteins.These proteins are subjected to hydrolysis and denaturation during themanufacturing process. The latex particles are insoluble in water, butthe presence of ammonium that is used to stabilize them and preservethem increases their solubility. The ammonium breaks the organellespresent in the latex and releases the soluble material. Fragments of theproteins give rise to low molecular weight polypeptides. About 240different polypeptides have been detected in the ammoniated latex, withmolecular mass between 5-200 kd. However, only 25% of these peptides,with molecular mass between 5-100 kd, show ligation with IgE of theserum of patients with latex allergy. (7,9, 11)

The main allergen in the latex is the rubber elongation factor (Hev b).There are 11 Hev b proteins (Hev b1 to Hev b11) within these Hev b5(18-20 kd) or latex profilin and Hev b6.02 (4.7 kd) hevein.Sensitization to Hev b5 is common in the health worker group. Theconcentration of Hev b1 in natural rubber products is reported to bebetween 18-40 mg/g, corresponding to 2-4% of extractable total proteinin the gloves. Hev b6.02 and Hev b5 are responsible for most latexallergens in medical gloves. (9, 11, 12, 15, 17, 25)

Latex allergens interact with carbohydrates. These allergens, such asHev b6.01, Hev b6.02 and Hev b11, are bound to oligosaccharides of Nacetylglucosamine thanks to a hevein domain. This type of domain hasalso been described in other plants, notably Pers a 1 (avocado), andsome others present in banana, kiwi and chestnut, which could explainthe fact that people sensitive to latex are also sensitive to thesefruits. (20)

Corn starch, used as a powder to lubricate gloves, acts as an allergentransporter when linked to latex proteins. When the particles areaerolized upon use of the gloves, exposure to latex occurs in allindividuals in the area. (13) Corn starch powder adheres to latexparticles and acts as a carrier. Talc (magnesium silicate) is capable ofbinding latex particles, however the union is irreversible as theycannot release the latex to the environment and it is a bad aeroallergentransporter for being heavier.

Another exposure route is the one that occurs when the allergens of thelatex come into contact with the tissues and mucous membranes of thepatient during surgical, dental or medical procedures. (13)

Sensitivity to latex: In the molecular structure of allergenic proteins,there are immunodominant regions, called epitopes, which interact withthe antigen binding fragments (Fab) of the specific IgE antibodies.Fab-allergen immune complexes have between 15 and 22 amino acidresidues. Of these, only 3 to 5 residues contribute to the bindingprocess through multiple non-covalent complementary bonds, originated byelectrostatic forces, mainly Van der Waals type. (19)

Patients with latex sensitivity have an altered humoral and cellularimmune response, which facilitates the reaction with environmentalantigens.

Increase of serum IgE: In 80% of the cases, IgE is capable of mediatingan immediate, but also a late, immunological response (FIG. 1). (20)

Surface Chemistry can be more or less defined as the study of chemicalreactions at interfaces. It is closely related to surface engineering,whose purpose is to modify the chemical composition of a surface byincorporating certain elements or functional groups that produce variousdesired effects or improvements in the properties of the surface orinterface. Surface Chemistry also overlaps with electrochemistry.Surface science is of particular importance for the field ofheterogeneous catalysis.

The adhesion of the gas or liquid molecules to the surface is known asadsorption. This may be due to chemical absorption or porphyrosorption.These are also included in Surface Chemistry.

The behavior of a solution based on the interface is affected by thesurface charge, dipoles, energies, and their distribution within thedouble electric layer.

Surface Chemistry develops and offers superior low cost productsformulated for the preparation of specialized surfaces and difficultsurface cleaning applications. These new chemicals are used in thepreparation and manufacture of high technology devices; however, theirusefulness also extends to cleaning industrial surfaces and preparation.Chemical surface discoveries can help achieve the most effective surfacepreparation, textures and cleaning needs of the solar cell and themanufacture of semiconductors.

Surface Chemistry consists of the study of the physical and chemicalprocesses that take place in the interfaces of the different habitualstates of matter: solids, liquids and gases. That is, it deals with thecontact zones between the different states of matter or phases where aset of atoms, small in quantity of species in comparison with the totalof atoms and molecules that constitute the phases, interacts and formnew chemical species. Therefore, Surface Chemistry must cover the basicconcepts of Solid State Chemistry and Coordination Chemistry.

The interest of Surface Chemistry, as an interdisciplinary field ofinvestigation, lies in the multiple applications and consequencesderived from the processes that take place on surfaces, among which wecan mention: electrochemical reactions, colloidal systems, detergencyand flotation, biological membranes, lubrication, corrosion,heterogeneous catalysis, etc. Limiting us to the application of theconcepts of Surface Chemistry in Heterogeneous Catalysis, we mustremember several key facts in relation to history and industrialapplications. Thus, it is revealing that, in the third decade of thenineteenth century, when J. J. Berzelius or M. Faraday began to writeabout the phenomenon of “catalysis”, they referred to a previous patentof 1831 consisting of a heterogeneous catalytic process, the manufactureof sulfuric acid.

No less important is another development of catalysts, this one from thebeginning of the 20th century, which facilitated the ammonia synthesisusing atmospheric nitrogen as reagent. This industrial process madepossible the production of fertilizers and the advent of modernagriculture, which, among other things, made it possible to feed anexponentially growing world population over the past century. We coulddelve into how the oil derivatives industry, based on various catalyticprocesses, has helped in the expansion of automotive or aviation use.

Also, the plastics, produced with polymerization catalysts of organiccompounds, are now present in all the materials that surround us. Andfrom all this we can conclude that catalysis, and therefore SurfaceChemistry, can be considered as technological pillars of the chemicalindustry and as key concepts in the resolution of new environmental andenergetic problems. From a final point of view, Surface Chemistry andits heterogeneous catalysis are present in new industrial andtechnological developments ranging from the production of hydrogen orthe transformation of biomass to photocatalysis, through fundamentaloperations to achieve a more sustainable chemical industry (GreenChemistry). The research situation in Surface Chemistry is exciting.

The emergence of new techniques of study, the evolution of experimentalanalytical methods and the support of computational methods have meantgoing from mere speculations about the nature of the surface centerswhere a process or reaction takes place to being able to achieve arational design of the synthesis of the catalytically active material(we would now call it nanomaterial). As for the challenges applied,catalytic reactions leading to enantiomers may have special appeal,since they require atomic scale control of both the surface of thecatalyst and the intermediate species that are being produced; that is,of the intermediates chemisorbed or bound to the surface site withchiral specificity.

From the point of view of the deep knowledge of the reactions that occuron a surface, we must emphasize the development of the techniques withtemporal resolution in the detection of the chemical changes, that is tosay those that allow us to follow the intermediates present in thesurface for periods of the order of the microsecond (10-6 seconds) up tothe PS (10-12 seconds) depending on the life span of the species and theconcrete reaction studied.

By way of example, we can indicate the spectroscopies of absorption ofX-rays capable of giving rise to spectra in a few microseconds. It isalso necessary to mention the studies that are carried out usingisotopically labeled compounds, in particular if they are operated inthe modern. Temporal Analysis of Products (TAP) reactors. Many of theseexperimental techniques are performed “in situ”, that is, while studyingthe chemistry under the conditions of the reaction that is taking place.

DETAILED DESCRIPTION OF THE INVENTION

The present invention consists of an emulsion made with silvernanoparticles which functions as a latex protein and other skinirritants blocker. The blocking process is based on the behavior of asolution based on the interface that is affected by the surface charge,dipoles, energies, and their distribution within the double electriclayer. The contact zones between the different states of matter orphases where a set of atoms, small in quantity of species in comparisonwith the total of atoms and molecules that constitutes the phases,interacts while forming chemical bonds.

For example, several processes take place on surfaces, among which wecan mention: electrochemical reactions, colloidal systems, detergencyand flotation, biological membranes, lubrication, corrosion,heterogeneous catalysis, etc.

The invention uses microfilm technology and refers to an application ofsurface chemistry with the final modification or protection of a surfacewhere a microfilm is generated with the bonding of chemical bondsbetween the polymers, the triacylglycerides generating a microfilm.

This invention is an emulsion based on silver nanoparticles, veryeffective for blocking latex protein and other skin irritants andthereby preventing it from contacting and affecting the skin byproducing a kind of invisible glove. This device allows the use of theproperties of silver as a protective barrier that blocks the latexprotein, being an antibacterial protective barrier for people workingwith their hands on risk surfaces such as patients' skin; food or money,thereby maximizing the properties of silver to cure recurrent skindiseases and avoiding bacterial contact.

It is an aqueous suspension of lipids with a high degree of saturationthat has a protective waxing effect, where alkali salts of the fattyacids associated with methylvinylether copolymer and silvernanoparticles generate an impenetrable film.

The mixture of the alkali salts of the fatty acids present in theselipids blocks the penetration of irritants such as latex protein orirritants.

It is a product intended to solve the number one problem of the latexglove industry that is the cutaneous allergic reaction caused by thelatex protein.

There is a precedent in Costa Rica, widely publicized in the press, inwhich the Constitutional Chamber through sentence No. 2003-1432 (4)forced the Costa Rican Social Security Fund to indemnify and provide asolution to a surgeon with a known sensitivity to latex. At that time,the only solution that the Social Security could offer is the supply ofgloves of another material in spite of being more expensive anddifficult to obtain.

This invention is a biotechnological solution, through the applicationof surface chemistry and microfilm technology, made with naturalproducts from our land (one of which is a waste of the Costa Ricanindustry). The formula is applied to the skin, producing a barrier thatprevents proteins in the latex from reaching or affecting the skin.

The reason and basis that led to the preparation of this invention isthe risk of developing allergy to latex, by all those users,continuously exposed to this allergen, due to their type of work. Manyof these workers are unable to carry out their work since they areinevitably no longer able to use this type of gloves. For these reasons,this invention is a solution that solves this problem.

Thanks to its formulation, a mixture of natural products provided bytriglycerides as active component, natural waxes and emulsifiers, formsa microfilm on the epidermis, blocking by interaction the transfer ofproteins from the latex to the skin, and prevents the development ofallergy: without any effect on the dermis and all its usefulness isapplicable to this allergen. It is also non-toxic and does not polluteecosystems.

In addition to its use to prevent the development of latex allergy, theinvention may block the action of irritants on the skin, such aschemicals, for example formalin, xylol, cement, or household substancessuch as dishwashing soaps.

The product is born in nanotechnology and is especially effective due toits particle size that will allow better results unlike what exists inthe state of the art. Ionic silver, when near a virus, fungi, bacteriaor any other unicellular organism, neutralizes the enzymes that they useto metabolize the oxygen, at the same time that they alter thepermeability of the membrane of the unicellular organism. In a fewminutes, these organisms are effectively asphyxiated. It is also knownthat ionic silver does not act on the cells of the host, as the enzymesare radically different from those of unicellular organisms. Similarly,silver acts as a neutralizer of the latex protein, creating a barrierthat protects the skin.

It is the only product on the world market that solves the allergyproduced by latex gloves. It is a white suspension, consisting ofnatural products such as vegetable oils, fatty acids from vegetableoils, essential oils, emulsifiers and thickeners. Especiallymanufactured to block the antigens contained in latex products,especially those of the latex glove, so that it does not reach thewearer's skin, while moisturizing the skin and allowing it to healthrough its own natural, processes. Most allergies will heal in 4 daysand more sensitization will be prevented, as long as the user continuesto block allergens with the present invention.

The invention thus blocks the direct contact of the latex materials[gloves, etc.] with the skin and therefore eliminates the inherentadverse allergic effect of the latex protein. It directly controls latexallergies, both type 1 and type 4, is 100% effective, prevents users[not yet sensitized] from any future sensitization and avoids problemsof workforce disabilities due to the dreaded latex allergy. It is aproduct that uses microfilm technology and surface chemistry. It is 100%safe as a result of a formulation that consists of natural activeingredients and presents a moisturizing and breathable barrier thatpromotes optimal natural conditions to accelerate healing, has no knownside effects, fast acting allergies to latex type 1 are resolved withina week and the microfilm technology, with which the present invention isformulated, enables close monitoring of the skin contours. It is theonly one of its kind, which allows glove users to cope with latexallergies and has additional benefits because it protects users from theeffects of harsh chemicals on the skin.

Composition.

The composition of the product is detailed below:

-   -   1.1. Stock solution

Water 88.2% Sodium hydroxide 0.35% Vegetable oil of palm oil 5.45%Parafan 5.10% Triton x 100 0.42% Triethanol amine 0.42% Sodium benzoate0.06%

-   -   1.2. Commercial Solution

Stock solution 10.0% Gantrez AN 139 1.0% Eucalyptus 0.5% Dissolutionwith silver nanoparticles (5 ppm) 98.5%

2. Materials section. The materials used in the composition are asfollows:

-   -   Asian Palm Oil.    -   Parafan, mixtures of vegetable fatty acids of vegetal origin,        produced as a result of its process of manufacture and the        purification of African palm oil.    -   Industrial grade sodium hydroxide.    -   Industrial grade sodium benzoate.    -   Gantrez AN 139.    -   Triton×100 whose active component is Nonyl phenol ethoxylate,        which is used in the product as an emulsifier.    -   Water. Deionized water    -   Triethanolamine: Industrial grade amine.    -   ASTEK Eucalyptus, code P0150 or similar,    -   Silver nanoparticles in deionized water. (Ag). These silver        nanoparticles are low concentrations suspended in distilled        water and produced by electric methods from silver electrodes        having an atomic mass of 107.868 g/mol, melting point of 960.5°        C., boiling point of 2000° C. and density at 15° C. of 10.49        g/mL. It is not attacked by water or atmospheric oxygen; it is        obscured by ozone and hydrogen sulfide. It is inert to many        acids, reacts easily with diluted nitric acid and hot sulfuric        acid. It is not sensitive to light in metallic form.    -   Generator of silver nanoparticles. The generator used is a Robey        device which uses a voltage source of 110-115 V and comprises a        current controller and produces silver nanoparticles in line. It        comprises two silver electrodes, placed in a compartment, and a        cellulose filter which restricts the passage of large particles        of silver, letting through nanoparticles between 60 and 140 nm.

Preparation of the Stock Solution:

5.10 kg of Parafan are placed in a 150 L stainless steel vessel andheated until they are melted and 1 L of a sodium hydroxide solutioncontaining 350 g of NaOH per liter is added slowly, then mixed until theParafan is dissolved. 5.45 kg of African palm oil are added to thisvessel; stirred and 420 g of triton X100 and 420 g of triethanolamineare then added. Water is added to make up to 100 L of solution andstirred to form a homogeneous white suspension and then 60 g of sodiumbenzoate is added, stirring until complete dissolution is achieved.

Commercial Solution:

87.2 L of water with silver nanoparticles are placed in a 150 L vesseland 10 L of stock solution is added under stirring and the mixture isstirred for 5 minutes and then 1.0 kg of Gantrez AN-139, which wasprepolymerized in a stainless steel vessel containing 1 L of deionizedwater at 40° C. is added, and continuous stirring is applied until theproduct becomes clear and viscous. 500 ml of eucalyptus oil is added tothis solution under stirring.

Physico-Chemical Specifications.

The physico-chemical specifications of the product are as follows:

Palm Oil.

This oil is characterized by a high content of short chain fatty acidsof 12 carbons or less. It has a relatively low and marked melting point,and is quite hard and fragile at lower temperatures. Because palm kerneloil has a high content of C18 unsaturated acids, it can produce abroader range of products, after fractionation and/or hydrogenation.Some physico-chemical properties are shown in the following table.

Physico-chemical characteristics of palm oil:

Specific weight 0.925-0.935 Melting point    19-26° C. Refraction pointat 40° C.  1.45-1.452 Saponification point 239-257 Iodine content 12-18

Soybean Oil.

Soybean oil is widely used in the preparation of refined products,although not as much as palm oil. Soybean oil has the characteristicsshown in the following table.

Density at 15° C. 0.922-0.930 Iodine content 121-135 Refractive index at25° C. 1.4729-1.4742 Saponification index 190-193 Melting point 27° C.

Essence of Eucalyptus.

Formula: C₁₀H₁₈O, M.=154.24, CAS [470-82-6]

EC Number (EINECS): 207-431-5

Appearance: Transparent, colorless liquid.

Odor: Characteristic.

Boiling point: 177° C.

Melting point: 1.5° C.

Flash point: 48° C.

Density (20/4): 0.924

Solubility: immiscible with water.

Mechanism of Action of the Invention.

The present invention provides a major part of the replacement of thephysiological lipids that are reduced in the stratum corneum in patientswith atopic dermatitis (AD). In addition, it replenished the skin withceramide, a key lipid lacking in the corneal layer in patients with AD.The compound offers an optimal ratio of 3:1:1 ceramides, cholesterol andfree fatty acids to help normalize the barrier function of the skin.

The invention acts by forming a vapor permeable barrier which allows ametabolic response to repair the skin and helps to normalize the pH inthe stratum corneum.

This emulsion is readily reacted with diluted nitric acid and hotsulfuric acid; and it is not sensitive to light in the metallic form. Inaddition, sodium hydroxide or anhydrous caustic soda is used toneutralize the acids.

BIBLIOGRAPHY Bibliographic References

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What is claimed is:
 1. A silver nanoparticle composition, comprising10.0% stock solution, 1.0% of a copolymer of methyl vinyl ether/maleicanhydride, 0.5% eucalyptus oil, and 88.5% solution with silvernanoparticles having a size of between 60 nm and 140 nm, wherein thestock solution consists of: a. 88.2% water; b. 0.35% sodium hydroxide;c. 5.45% African palm vegetable oil; d. 5.10% mixture of fatty acids ofvegetable origin; e. 0.42% Polyoxyethylene octyl phenyl ether; f. 0.42%triethanol amine; and g. 0.06% sodium benzoate.
 2. The composition ofclaim 1, wherein the silver nanoparticles have the followingcharacteristics: a. they are suspended in distilled water at aconcentration of 5 ppm and produced by electric methods from silverelectrodes; b. they have an atomic mass of 107.868 g/mol; c. theirmelting point is 960.5° C.; d. their boiling point is 2000° C.; e. theirdensity at 15° C. is 10.49 g/mL; f. they are not attacked by water oratmospheric oxygen and obscured by ozone and hydrogen sulfide; g. theyare inert to many acids, react easily with diluted nitric acid and hotsulfuric acid; and h. they are not sensitive to light in the metallicform.
 3. The composition of claim 1, wherein the African palm oil hasthe following characteristics: a. it has a specific weight of0.925-0.935 g/ml; b. it has a melting point of 19-26° C.; c. it has arefraction point at 40° C. of 1.450-1.452; d. it has a saponificationpoint of 239-257 mg/g; and e. it has an iodine content of 12-18 giodine/100 grams of product.
 4. The composition of claim 1, wherein theeucalyptus oil is characterized by: formula: C₁₀H₁₈O, M.=154.24, CAS[470-82-6]; its appearance is that of a clear and colorless liquid; aboiling point of 177° C.; a melting point of 1.5° C.; a flash point of48° C.; a density (20° C. /4° C.) of 0.924; and a solubility being thatit is immiscible with water.
 5. The composition of claim 1, wherein thesodium hydroxide is used to neutralize the mixture of fatty acids ofvegetable origin.
 6. The composition of claim 1, wherein the water isdistilled or deionized.